The root cause cannot be identified.There is limited device specific information provided, no batch number or product type was available for evaluation.Without a batch reference number, a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.No product quality related trend was identified for the subclass adverse event safety request for investigation.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid the risk of blisters and other skin irritations.The manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure packaged product quality.
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On 07-dec-2022, a spontaneous report was received from social media regarding a female (age not provided) who used a thermacare heat wrap.Medical history and concomitant products were not provided.On an unspecified date, reported as "years ago" (in reference to 07-dec-2022), the consumer used a thermacare heat wrap.On an unspecified date, after using the product, the heat wrap burned her "so bad that her skin came off trying to remove it." she indicated she would stick her heating pad and not use the product again.No additional information is expected as reporter contact details were not provided.
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